Nomad Power Solutions (NMAD) risk factors, FY2025 10-K

Risks Related to Our Financial Resources and Capital Needs

1. 01We are engaged in early-stage research and as such might not be successful in our efforts to develop a portfolio of commercially viable products
2. 02We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future
3. 03There is substantial doubt about our ability to continue as a going concern32% rewritten
4. 04We currently have no source of revenues. We might never generate revenues or achieve profitability
5. 05Our efforts to integrate acquired businesses may not be successful, and this may adversely affect our financial resultsNew
6. 06Acquiring or implementing new business lines or offering new products and services may subject us to additional risksNew
7. 07We compete in highly competitive markets, and we may lose market share to companies with greater resources or more effective technologies or be forced to reduce our pricesNew
8. 08Our ability to use net operating losses to offset future taxable income might be subject to limitations99% rewritten
9. 09Additionally, after weighing up all available positive and negative evidence for the period ending 12/31/2025, the Company has recorded a full valuation allowanceNew

Risks Related to the Development and Regulatory Approval of Our Product Candidates

1. 10Clinical-stage biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which might entail substantial risk
2. 11We might find it difficult to enroll patients in our clinical trials which could delay or prevent the start of clinical trials for our product candidate
3. 12Clinical drug development involves a lengthy and expensive process with an uncertain outcome
4. 13Risks associated with operating in foreign countries could materially adversely affect our product development
5. 14Any of these events could prevent us from achieving or maintaining market acceptance of our lead product candidate, if approved
6. 15There is a risk that one or more of our clinical trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to our drug candidate or to another company’s drug used in combination in one of our clinical trials
7. 16Our future success is dependent on the regulatory approval of our lead product candidate
8. 17Our lead product candidate and future product candidates could fail to receive regulatory approval from the FDA
9. 18Failure to obtain regulatory approval in international jurisdictions would prevent our lead product candidate from being marketed abroad
10. 19Even if our current primary product candidate received regulatory approval, it might still face future development and regulatory difficulties
11. 20The occurrence of any event or penalty described above might inhibit our ability to successfully commercialize our intended product and generate revenues

Risks Related to Our Dependence on Third Parties

1. 21We depend on certain key scientific personnel for our success who do not work full time for us. The loss of any such personnel could a dversely affect our business, financial condition and results of operations90% rewritten
2. 22Effective September 1, 2025, Mr. van der Baan resigned from the Board of Directors and resigned as President of the CompanyNew
3. 23Our business may suffer if we are not able to hire and retain qualified personnelNew
4. 24We expect to rely heavily on third parties for the conduct of clinical trials of our product candidates. If these clinical trials are not successful, or if we or our collaborators are not able to obtain the necessary regulatory approvals, we will not be able to commercialize our product candidates79% rewritten
5. 25We expect to rely on collaborative partners and CROs for their performance and management of clinical trials of our product candidatesNew
6. 26The development process necessary to obtain regulatory approval is lengthy, complex and costly. If we or our collaborative partners do not obtain necessary regulatory approvals, then our business would not be successful, and the market price of our common stock could decline substantially
7. 27Business interruptions could adversely affect future operations, revenues, and financial conditions, and might increase our costs and expenses
8. 28Our failure to find third party collaborators to assist or share in the costs of product development could materially harm our business, financial condition or results of operations
9. 29We might be subject to claims by third parties asserting that our employees, consultants, collaborators contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
10. 30The financial results of our Liora LiGHT system business may be unpredictable and if our proton therapy customers are unsuccessful, our financial results will be adversely affectedNew
11. 31Our Liora LiGHT system business may subject us to increased liabilityNew

Risks Related to Our Intellectual Property

1. 32Our patents and patent applications are owned solely by our wholly owned subsidiary, Lixte Biotechnology, Inc., except in several instances where they are jointly owned with one of our collaborators
2. 33If we do not obtain patent term extension in the United States under the Hatch-Waxman Act or in foreign countries under similar legislation, our business might be materially harmed
3. 34If we fail to comply with our obligations in agreements under which we have licensed or, might license, intellectual property rights from third parties, or if we otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business
4. 35If disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may be unable to successfully develop or commercialize the affected product candidates
5. 36We might infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increasing the costs of commercializing our product candidates
6. 37We might be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of one or more third parties
7. 38Our intellectual property might not be sufficient to protect our intended products from competition, which might negatively affect our business as well as limit our partnership or acquisition appeal
8. 39If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovations, we might suffer competitive harm
9. 40If we are unable to protect our intellectual property rights, our competitors might develop and market products with similar or identical features that might reduce demand for our potential products
10. 41We will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to the extent that such intellectual property rights are covered by valid and enforceable patents or are effectively maintained as trade secrets and we enforce these rights

Risks Related to Commercialization of Our Current Product Candidate and Future Product Candidates

1. 42Our commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and cancer treatment centers
2. 43Even if we are able to commercialize our lead product candidate or any future product candidates, the products might not receive coverage or adequate reimbursement from third party payors in the United States and in other countries in which we seek to commercialize our intended products, which could harm our business
3. 44Healthcare legislative measures aimed at reducing healthcare costs might have a material adverse effect on our business and results of operations
4. 45Price controls might be imposed in foreign markets, which might adversely affect our future profitability
5. 46Our performance depends on successful improvements to our existing products and services, commercialization of new products and services and increasingly on our ability to anticipate emerging trends in oncology diagnosis, treatment and managementNew

Risks Related to Healthcare Compliance Regulations

1. 47Our employees might engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
2. 48Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we might develop

Risks Related to our Business Operations

1. 49We face substantial competition, which might result in others discovering, developing or commercializing products before or more successfully than we do
2. 50Significant disruptions of information technology systems, computer system failures or breaches of information and cyber security could adversely affect our business
3. 51We might need to grow the size of our organization in the future, and we might experience difficulties in managing this growth54% rewritten
4. 52Mr. Pursglove’s simultaneous service as our Chief Executive Officer and member of our Board of Directors, and as Chief Executive Officer and member of the Board of Directors of Powell Max Ltd., may create conflicts of interest and may adversely affect management attention, financial reporting and decision-makingNew
5. 53Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business, financial condition and stock price

Risks Related to Owning our Securities

1. 54Provisions of certain warrants could discourage a change-in control transaction involving a third party71% rewritten
2. 55Our management has broad discretion over the use of the proceeds from any stock offerings we may conduct in the future and we may apply it to uses that do not improve our operating results or the value of our common stock
3. 56The price of our common stock might fluctuate substantially

Risks Related to the Company’s Common Stock

1. 57The Company’s common stock are traded on The Nasdaq Capital Market under the symbols “LIXT”
2. 58On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings83% rewritten
3. 59A sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline
4. 60Market and economic conditions might negatively impact our business, financial condition and share price
5. 61If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume might decline
6. 62Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall
7. 63We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares
8. 64We might be at risk of securities class action litigation
9. 65Our Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law might have anti-takeover effects that could discourage, delay or prevent a change in control, which might cause our stock price to decline
10. 66Financial reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters
11. 67If we fail to comply with the rules under Sarbanes-Oxley related to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult